NCT00706537

Phase 1 Pharmacokinetic Study Of CP-945598 In Patients With NASH

A Multiple Dose, Randomized, Double-Blind (3rd Party Open), Placebo-Controlled Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of CP-945598 In Subjects With Nonalcoholic Steatohepatitis (NASH)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

CP-945598 is a potent and selective Cannabinoid-1 (CB1) receptor antagonist currently being developed for the treatment of obesity. CP-945598 is also being considered as a potential treatment for non-alcoholic steatohepatitis (NASH). This study will investigate the steady-state safety, toleration and pharmacokinetics of multiple oral dose administration of CP-945598. Results will be used to estimate the pharmacokinetic characteristics in NASH patients and underwrite the safety of this compound prior to any further studies in NASH patients.

Conditions

• Non-Alcoholic Steatohepatitis(NASH)

Interventions

Type	Name	Description
DRUG	Active treatment	20 mg CP-945598 as 15 and 5 mg tablet once daily for 3 weeks
DRUG	Placebo	Placebo as two tablets once daily for three weeks

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2008-06-27
• Last updated: 2009-08-13

Locations

3 sites across 1 country: United States